Surufatinib With or Wothout Immunotherapy for Advanced Colorectal Cancer in Later Line

NCT05372198 | Unknown Phase 2

• 1 other identifier: LCKY2021030
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, cohort clinical study to investigate the efficacy and safety of surufatinib with or without immunotherapy in patients with advanced colorectal cancer who failed front-line anti-angiogenic TKI therapy. Patients have to received at least a second-line standard therapy or cannot tolerate other treatments, and have previously failed anti-angiogenic TKIs therapy(including but not limited to: fruquintinib/regorafenib/anlotinib) / apatinib, and are resistant to treatment, disease progression, intolerable toxicity or no continued benefit as assessed by investigator after therapy). Patients who met the eligibility criteria are randomized 1:2 into two cohorts (cohort 1: surufatinib, cohort 2: surufatinib plus immunotherapy) to receive treatment until disease progression, death, unacceptable toxicity, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest. The primary study endpoint was PFS(progression free survival).

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

  36 months

Secondary Outcomes (5)

• overall survival (OS)

  36 months

• objective response rate (ORR)

  36 months

• disease control rate (DCR)

  36 months

• quality of life (QoL) assessed by the QLQ-C30

  36 months

• adverse events (AE)

  36 months

Study Arms (2)

Cohort 1: Surufatinib Monotherapy

EXPERIMENTAL

Patients who met the eligibility criteria took Surufatinib 300mg qd, every 3 weeks as a cycle

Drug: Chohort 1: Surufatinib

Cohort 2: Surufatinib with immunotherapy

EXPERIMENTAL

Patients who met the eligibility criteria took Surufatinib with immunotherapy: Surufatinib:250mg qd, every 3 weeks as a cycle Immunotherapy: Refer to the instructions for the use of immunotherapy, every 3 weeks as a cycle

Drug: Chohort 2: Immunotherapy; Drug: Chohort 2: Surufatinib

Interventions

Chohort 1: Surufatinib DRUG

Surufatinib 300mg, qd, every 3 weeks as a cycle

Cohort 1: Surufatinib Monotherapy

Chohort 2: Immunotherapy DRUG

Refer to the instructions for the use of immunotherapy, every 3 weeks as a cycle

Cohort 2: Surufatinib with immunotherapy

Chohort 2: Surufatinib DRUG

Surufatinib 250mg, qd, every 3 weeks as a cycle

Cohort 2: Surufatinib with immunotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent has been signed；
• Age ≥ 18 years, ≤80 years；
• Histologically confirmed advanced colorectal cancer；
• Patients have to received at least a second-line standard therapy or cannot tolerate other treatments, and have previously failed anti-angiogenic TKIs therapy(including but not limited to: fruquintinib/regorafenib/anlotinib) / apatinib, and are resistant to treatment, disease progression, intolerable toxicity or no continued benefit as assessed by investigator after therapy)；
• ECOG 0-2；
• Life expectancy ≥ 12 weeks
• Patients must have adequate organ function；
• Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration.

You may not qualify if:

• Have previously received surufatinib or immunotherapy;
• Have received other systemic anti-tumor therapies within 2 weeks(eg.chemotherapy or radiotherapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy);
• Participating in other drug clinical trials within 4 weeks before recruited;
• Have received major surgery within 4 weeks;
• Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
• Pleural effusion or ascites causing relevant clinical symptoms , including respiratory syndrome (dyspnea≥CTC AE grade 2)；
• Clinically significant electrolyte abnormality；
• Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 90mmHg regardless of any antihypertensive drugs；
• Patient currently has any disease or condition that affects drug absorption, or the patient cannot take surufatinib orally；
• Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI；
• Have evidence or history of bleeding tendency within 3 months or thromboembolic events within 12 months before enrollment;
• Clinically significant cardiovascular disease;
• Active or uncontrolled serious infection (≥CTCAE grade 2 infection);
• Clinical uncontrolled active infections, including human immunodeficiency virus (HIV) infection, active hepatitis B / C (HBV DNA Positive\[1×104 copies/mL or \>2000 IU/ml\], HCV RNA positive\[\>1×103 copies/mL\]);
• Patients have untreated central nervous system metastasis；

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Xu Huiting, M.D.

CONTACT

+86-15307176219; 2891533@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abdominal Oncology Department，Deputy Director

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: March 30, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)